Senior Associate, LCM Execution

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description: Let’s do this. Let’s change the world.
We are seeking people who thrive in a dynamic, cross-functional environment and passionate about delivering operational excellence across the product lifecycle.

In this vital role, you will be responsible for the planning, coordination and execution of post-approval Lifecycle Management activities and Change Control implementation across Amgen's commercial portfolio.

You will ensure timely delivery of compliant and high-quality execution of CMC variations, labeling updates, SKU rationalizations, product discontinuations and other lifecycle initiatives supporting both Regional Supply Chain Operations and Manufacturing Site Operations.

Roles & Responsibilities:

• Oversee the execution of post-approval Lifecycle Management activities across Amgen's commercial portfolio.
• Ensure successful delivery of CMC variations, labeling changes, SKU rationalizations, product discontinuations and other lifecycle initiatives.
• Translate Product Lifecycle Team (PLT) decisions into executable work plans and coordinate implementation across the Lifecycle Management Execution team.
• Ensure integrated project plans are developed, maintained and executed in alignment with agreed timelines and business priorities.
• Monitor portfolio progress, proactively manage project risks and remove execution barriers.

• Execution of Change Controls supporting Lifecycle Management activities in accordance with GMP, regulatory requirements and Amgen procedures.
• Ensure Change Controls are planned, coordinated, implemented and closed within agreed timelines.
• Coordinate execution across Manufacturing, Quality, Regulatory Affairs, Supply Chain, Planning and other impacted functions.
• Monitor Change Control performance, compliance and milestone achievement.
• Escalate critical risks, issues and delays, driving timely resolution with key stakeholders.
• Ensure accurate project documentation, execution records and audit readiness.

• Partner with Product Lifecycle Teams (PLTs), Regional Operations Leads, Manufacturing Sites, Regulatory Affairs, Quality Assurance, Artwork & Labeling, Planning and Procurement organizations to ensure successful implementation of lifecycle initiatives.
• Support implementation planning for complex lifecycle initiatives requiring coordination across multiple functions and geographies.
• Build strong collaborative relationships across Regional and Site Operations to ensure successful execution.

Functional Skills

Must-Have Skills:

• Bachelor’s degree in supply chain management, Engineering, Life Sciences, Business or related discipline.
• 5+ years of experience in pharmaceutical Supply Chain, Manufacturing, Product Lifecycle Management, Regulatory Affairs or Project Management.
• Strong knowledge of post-approval Lifecycle Management processes, CMC variations, labeling changes and Change Control execution.
• Experience working in GMP-regulated pharmaceutical manufacturing environments.
• Strong project management, stakeholder management and organizational leadership skills.
• Excellent analytical, communication and problem-solving capabilities.

Good-to-Have Skills:

• Experience working within Product Lifecycle Teams (PLTs).
• Knowledge of pharmaceutical commercialization processes.
• Experience with SAP, project portfolio management tools and Smartsheet/MS Project.
• Lean, Six Sigma or Operational Excellence experience.
• Project Management certification (PMP, PRINCE2 or equivalent).

Professional Certifications

Preferred:

• Master’s degree in supply chain management, Engineering, Business, or related field.
• PMP, PRINCE2 or equivalent Project Management certification.
• Lean Six Sigma Green Belt or equivalent Operational Excellence certification.

Soft Skills:

• Strong verbal and written communication skills.
• Strong planning, prioritization and organizational skills.
• Ability to lead multiple priorities in a fast-paced environment.
• High degree of initiative, accountability and ownership.
• Strong analytical and decision-making capabilities.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.